A Randomized trial of an Asthma Internet Self-management Intervention (RAISIN): study protocol for a randomized controlled trial

Trials

Frances S Mair³  Rekha Chaudhuri⁴  Kathryn Saunderson³  Karolina Agur³  Alex McConnachie²  Neil C Thomson⁴  Sally Wyke¹  Deborah Morrison³ 

[1] Deputy Director, Institute of Health and Wellbeing/Interdisciplinary Research Professor, College of Social Sciences, Rm 204, 25-28 Bute Gardens, University of Glasgow, Glasgow G12 8RS, UK;Robertson Centre for Biostatistics, Boyd Orr Building, University Avenue, University of Glasgow, Glasgow G12 8QQ, UK;General Practice & Primary Care, 1 Horselethill Road, Institute of Health & Wellbeing, University of Glasgow, Glasgow G12 9LX, UK;Institute of Infection, Immunity and Inflammation, Gartnavel General Hospital, 1053 Great Western Road, University of Glasgow, Glasgow G12 0YN, UK

关键词: Behaviour change;    Inhaled corticosteroids;    Complex intervention;    Randomized controlled trial;    E-health;    Adherence;    Self-management;    Asthma;   

Others  :  805733
DOI  :  10.1186/1745-6215-15-185

 received in 2014-02-13, accepted in 2014-05-02,  发布年份 2014

【 摘 要 】

Background

The financial costs associated with asthma care continue to increase while care remains suboptimal. Promoting optimal self-management, including the use of asthma action plans, along with regular health professional review has been shown to be an effective strategy and is recommended in asthma guidelines internationally. Despite evidence of benefit, guided self-management remains underused, however the potential for online resources to promote self-management behaviors is gaining increasing recognition. The aim of this paper is to describe the protocol for a pilot evaluation of a website ‘Living well with asthma’ which has been developed with the aim of promoting self-management behaviors shown to improve outcomes.

Methods/Design

The study is a parallel randomized controlled trial, where adults with asthma are randomly assigned to either access to the website for 12 weeks, or usual asthma care for 12 weeks (followed by access to the website if desired). Individuals are included if they are over 16-years-old, have a diagnosis of asthma with an Asthma Control Questionnaire (ACQ) score of greater than, or equal to 1, and have access to the internet. Primary outcomes for this evaluation include recruitment and retention rates, changes at 12 weeks from baseline for both ACQ and Asthma Quality of Life Questionnaire (AQLQ) scores, and quantitative data describing website usage (number of times logged on, length of time logged on, number of times individual pages looked at, and for how long). Secondary outcomes include clinical outcomes (medication use, health services use, lung function) and patient reported outcomes (including adherence, patient activation measures, and health status).

Discussion

Piloting of complex interventions is considered best practice and will maximise the potential of any future large-scale randomized controlled trial to successfully recruit and be able to report on necessary outcomes. Here we will provide results across a range of outcomes which will provide estimates of efficacy to inform the design of a future full-scale randomized controlled trial of the ‘Living well with asthma’ website.

Trial registration

This trial is registered with Current Controlled Trials ISRCTN78556552 on 18/06/13.

【 授权许可】

   
2014 Morrison et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Masoli M, Fabian D, Holt S, Beasley R, Global Initiative for Asthma (GINA) Program: The global burden of asthma: executive summary of the GINA Dissemination Committee report. Allergy 2004, 59:469-478.
• [2]Bahadori K, Doyle-Waters MM, Marra C, Lynd L, Alasaly K, Swiston J, Fitzgerald JM: Economic burden of asthma: a systematic review. BMC Pulm Med 2009, 9:24. BioMed Central Full Text
• [3]Rabe KF, Adachi M, Lai CKW, Soriano JB, Vermeire PA, Weiss KB, Weiss ST: Worldwide severity and control of asthma in children and adults: the global asthma insights and reality surveys. J Allergy Clin Immunol 2004, 114:40-47.
• [4]Haughney J, Barnes G, Partridge M, Cleland J: The living & breathing study: a study of patients’ views of asthma and its treatment. Prim Care Respir J 2004, 13:28-35.
• [5]British Thoracic Society: British guideline on the management of Asthma. Thorax 2008, SupplIV:iv1-iv121.
• [6]Powell H, Gibson PG: Options for self-management education for adults with asthma [Systematic Review]. Cochrane Database Syst Rev 2002., CD004107
• [7]Thoonen BP, Schermer TR, van den Boom G, Molema J, Folgering H, Akkermans RP, Grol R, van Weel C, van Schayck CP: Self-management of asthma in general practice, asthma control and quality of life: a randomised controlled trial. Thorax 2003, 58:30-36.
• [8]Gibson PG, Powell H, Wilson A, Abramson MJ, Haywood P, Bauman A, Hensley MJ, Walters EH, Roberts JJL: Self-management education and regular practitioner review for adults with asthma [Systematic Review]. Cochrane Database Syst Rev 2002, CD001117.
• [9]GINA: From the Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA). 2012. Available from: http://www.ginasthma.org/ webcite
• [10]Aarne L: Guided self management of asthma − how to do it. BMJ 1999, 319:759-760.
• [11]Sims EJ, Price D, Haughney J, Ryan D, Thomas M: Current control and future risk in Asthma management. Allergy Asthma Immunol Res 2011, 3:217-225.
• [12]Horne R: Compliance, adherence, and concordance: implications for asthma treatment. Chest 2006, 130:65S-72S.
• [13]Heaney LG, Horne R: Non-adherence in difficult asthma: time to take it seriously. Thorax 2012, 67:268-270.
• [14]Pound P, Britten N, Morgan M, Yardley L, Pope C, Daker-White G, Campbell R: Resisting medicines: a synthesis of qualitative studies of medicine taking. Soc Sci Med 2005, 61:133-155.
• [15]van der Meer V, Bakker MJ, van den Hout WB, Rabe KF, Sterk PJ, Kievit J, Assendelft WJ, Sont JK, SMASHING (Self-Management in Asthma Supported by Hospitals, ICT, Nurses and General Practitioners) Study Group: Internet-Based Self-management plus education compared with usual care in Asthma. Ann Intern Med 2009, 151:110-120.
• [16]Chan DS, Callahan CW, Hatch-Pigott VB, Lawless A, Proffitt HL, Manning NE, Schweikert M, Malone FJ: Internet-based home monitoring and education of children with Asthma is comparable to ideal office-based care: results of a 1-year Asthma in-home monitoring trial. Pediatrics 2007, 119:569-578.
• [17]Rasmussen LM, Phanareth K, Nolte H, Backer V: Internet-based monitoring of asthma: a long-term, randomized clinical study of 300 asthmatic subjects. J Allergy Clin Immunol 2005, 115:1137-1142.
• [18]Hashimoto S, Brinke AT, Roldaan AC, van Veen IH, Moller GM, Sont JK, Weersink EJ, van der Zee JS, Braunstahl GJ, Swinderman AH, Sterk PJ, Bel EH: Internet-based tapering of oral corticosteroids in severe asthma: a pragmatic randomised controlled trial. Thorax 2011, 66:514-520.
• [19]Van DMV, Van den Hout WB, RABE KF, Bakker MJ, Sterk PJ, Assendelft WJ, Kievit J, Sont JK: Cost-effectiveness of internet-based self-management compared with usual care in asthma. PLoS One 2011, 6:e27108.
• [20]Morrison D, Wyke S, Agur K, Cameron EJ, Docking RI, MacKenzie AM, McConnachie A, Raghuvir V, Thomson NC, Mair FS: Digital Asthma self-management interventions: a systematic review. J Med Internet Res 2014, 16:e51.
• [21]Hinchliffe A, Mummery WK: Applying usability testing techniques to improve a health promotion website. Health Promot J Austr 2008, 19:29-35.
• [22]Vizri RA: Refining the test phase of usability evaluation: how many subjects is enough? Hum Factors 1992, 34:457-468.
• [23]Medical Research Council: Developing and evaluating complex interventions: new guidance. London: MRC; 2008.
• [24]Public Health Guidance NICE: Behaviour Change at Population, Community and Individual Levels. London: NICE; 2007.
• [25]Arain M, Campbell MJ, Cooper CL, Lancaster GA: What is a pilot or feasibility study? a review of current practice and editorial policy. BMC Med Res Methodol 2010, 10:67. BioMed Central Full Text
• [26]Lancaster GA, Dodd S, Williamson PR: Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract 2004, 10:307-312.
• [27]Juniper EF, O’Byrne PM, Guyatt GH, Ferrie PJ, King DR: Development and validation of a questionnaire to measure asthma control. Eur Respir J 1999, 14:902-907.
• [28]Juniper EF, Guyatt GH, Cox FM, Ferrie PJ, King DR: Development and validation of the mini Asthma quality of life questionnaire. Eur Respir J 1999, 14:32-38.
• [29]Hibbard JH, Mahoney ER, Stockard J, Tusler M: Development and testing of a short form of the patient activation measure. Health Serv Res 2005, 40:1918-1930.
• [30]Group EQ: EuroQol–a new facility for the measurement of health-related quality of life: the EuroQol group. Health Pol 1990, 16:199-208.
• [31]Morisky DE, Ang A, Krousel-Wood M, Ward HJ: Predictive validity of a medication adherence measure in an outpatient setting. J Clin Hypertens (Greenwich) 2008, 10:348-354.
• [32]Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J: Standardisation of spirometry. Eur Respir J 2005, 26:319-338.
• [33]ATS/ERS: ATS/ERS recommendations for standardized procedures for the online and offline measurement of exhaled lower respiratory nitric oxide and nasal nitric oxide, 2005. Am J Respir Crit Care Med 2005, 171:912-930.
• [34]Yardley L, Kirby S: Evaluation of booklet-based self-management of symptoms in meniere disease: a randomized controlled trial. Psychosom Med 2006, 68:762-769.